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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K221571
Device Name InMode Multi-system
Applicant
InMode , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Amit Goren
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
18 Hata'As St. , Sute 21
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
GEI   ISA   NUV   ONF   PBX  
Date Received05/31/2022
Decision Date 06/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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